Pirfenidone Kitoscell LP 600 mg 90 Tabs

Please consult your physician before taking any medication. To be used in patients with liver inflammation and fibrosis. Also indicated in the treatment of pulmonary fibrosis. As a selective cytokine modulating drug such as TNF-a, TGF-beta, PDGF and VEGF, amongst other cytokines KITOSCELL ® LP Tablets are indicated in conditions that occur with chronic fibrosis associated with tissue damage, such as advanced liver fibrosis or fibrosis lung, where required to prevent, reduce, inhibit or reverse fibrotic lesions. Treatment with LP KITOSCELL ® Tablets should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of liver fibrosis and / or lung. DOSAGE AND ADMINISTRATION: Route of administration : Oral . Adults: From 1,200 mg – 2,400 mg per day in divided doses every 12 hours. Children who can swallow tablets from 12 years of age: 600 mg – 1,200 mg per day in divided doses every 12 hours. Weight dose: Body surface area : 250 mg – 500 mg / dose per m2 of SC , 2 times daily . The tablet may be fractional when required , based on the recommended dosage. Preferably ingest 20 to 30 minutes after food . In patients with severe hepatic impairment is recommended that monitoring of aminotransferases and the dose should be adjusted according to the values ​​of the study under the following recommendation: • Patients with ALT aminotransferase within normal limits , keep the dose . • Patients with ALT aminotransferase increased 3-5 times above the normal limit, should be discontinued any medications that may alter the results of the study and closely monitor the patient , according to the judgment of the treating physician. KITOSCELL LP ® Tablets can remain unchanged or be reduced dosage for a while , returning to the maximum dose of progressive and phased manner. • Patients with increased aminotransferases more than 5 times or less than 5 times accompanied by hyperbilirubinemia or severe symptoms of advanced liver failure, it is recommended to discontinue treatment permanently. Must be prescribed by a physician . RECOMMENDED STORAGE : Store at room temperature in a dry place . CHANGES IN RESULTS OF LABORATORY TESTS KITOSCELL LP ® Tablets may alter some enzymes such as ALT and AST is why it is recommended that liver function tests before initiation of treatment and every month during the first 6 months and then every 3 months. According to the laboratory results , the doctor may recommend a dose adjustment . Contraindications KITOSCELL LP ® Tablets are contraindicated in patients allergic to components of its formula patients. The concomitant use of fluvoxamine is contraindicated if the patient is already taking fluvoxamine should be discontinued this medication before starting treatment with LP KITOSCELL ® Tablets. Other treatments that inhibit CYP1A2 or other CYP isoenzymes that may be involved in the metabolism of KITOSCELL LP ® Tablets (CYP2C9 , 2C19 and 2D6 ) should also be avoided. Terminal liver disease. Severe renal impairment ( CrCl <30 ml / min) or end-stage renal disease requiring dialysis. ADVERSE REACTIONS : The side or side effects have been of little clinical magnitude and transiently . At therapeutic doses, have been reported gastrointestinal symptoms such as stomach pain, nausea or dizziness, decrease if ingested after meals . And occasionally he has performed photosensitivity dermatitis . These side effects have not merited suspension or withdrawal of treatment ; since when there have been , disappear within two to three weeks.